Consider first the problem of incontinence. Incontinence and other disorders of the anus and bladder functions are major medical problems, particularly in geriatric medicine.
Where incontinence is tolerated, considerable time is spent by nursing staff in regular, almost continuous, changing of a patient's clothes and bedding. However, incontinence is not generally acceptable by a sufferer or the family of a sufferer, and various techniques have been developed to provide some control of incontinence.
Some of these control techniques involve "mechanical" control apparatus. One example of "mechanical" control is the use, with males, of continuous catheterization, with a bag for collection. This has been used for some time, but is an unpleasant solution and is disliked by patients. Another "mechanical" control device, developed for control of urinary incontinence in women by L. E. Edwards (and described in an article in the British Medical Journal, July 1970 issue, at page 104) is a triangular device having a steel wire projection which is curved and is provided with a corrugated plastic pad. The steel wire fits into the vagina and he corrugated pad exerts gentle pressure on the urethra to prevent discharge of urine. This device has not yet received wide acceptance.
Electrical control of the bladder and anus has also been attempted previously. This electrical control has developed in two major ways. One of these is the implantation of electrodes into the flesh of a patient, while the other is the use of rectal tampons which are fitted with electrodes.
The first insertion of electrodes into the pelvic floor by surgery, followed by the application of electrical voltages to the electrodes, is usually attributed to K. P. S. Caldwell, who reported his work in various papers that were published in the early and mid-1960's. More recent reference to this technique is found in the papers by
(a) L. Edwards, N. Harrison and J. P. Williams, entitled "Investigation and treatment of Resistant Urinary Incontinence", which was published in the British Medical Journal, in the 6th March 1971 issue, at pages 543-545; and PA1 (b) D. C. Merrill, C. Conway and W. deWolf entitled "Urinary Incontinence-treatment with electrical stimulation of the pelvic floor", which was published in Urology, Volume V, January, 1975, at pages 67 to 72. PA1 (i) applying a pair of electrodes to the skin in the region where the pudendal nerve channel runs near to the body surface; and PA1 (ii) applying to the electrodes a continuous electrical signal at a voltage of up to about 50 volts, and at a frequency in the range of from 10 Hz to 80 Hz, preferably in the range of from 20 Hz to 40 Hz. PA1 (a) applying a first electrode to the skin of the inner forearm of the sufferer, at the side corresponding to the side of the head affected by the migraine or the side of the head most affected by the vascular headache; PA1 (b) applying a second electrode to the acupuncture hot spot of the neck on the same side of the body as the first electrode; and PA1 (c) applying an electrical signal having a frequency of from 30 Hz to 70 Hz and a voltage in the range from 30 volts to 80 volts between the first and second electrodes for a period of from about 10 minutes to about 15 minutes. PA1 (a) winding a length of muscle around the intestine connected to the stoma in the region adjacent to the stoma; PA1 (b) applying a pair of electrodes to the skin in the region of the length of muscle; and PA1 (c) applying to the electrodes a continuous electrical signal at a voltage in the range 20 volts to 60 volts and at a frequency in the range 10 Hz to 80 Hz, PA1 (a) a pair of electrodes; PA1 (b) a source of low voltage, low frequency electrical signal comprising an oscillator adapted to produce output signals at a frequency in the range 10 Hz to 100 Hz; and PA1 (c) means to control the voltage amplitude of the output signals of the oscillator.
The latter paper has illustrations of the surgical electrode implantation that is necessary. Both papers refer also to the use of rectal tampons fitted with electrodes, which have been referred to in other publications as "transrectal tampons" and "intra-anal plugs".
The rectal tampon with fitted electrodes was first developed by B. R. Hopkinson and R. Lightwood, and described in their papers published in The Lancet (5th February 1966 issue, pages 297 to 298) and in the British Journal of Surgery (Volume 54, 1967, pages 802 to 805). The successful use of this form of control of incontinence has also been reported by E. S. Glen (in his paper entitled "Effective and safe control of incontinence by the intra-anal plug electrode", which was published in the British Journal of Surgery, Volume 38, 1971, pages 249-252. Recently the anal plug or rectal tampon aid has become available commercially in the U.S.A. (on prescription), being marketed by Mentor Corporation, Minneapolis, under the trade mark "Continaid".
It is interesting to note that notwithstanding the acclaim given to the rectal tampon or anal plug control technique, which uses internal stimulation of the pudendal nerve of a patient but does not require a surgical procedure for its adoption by a patient, Edwards, Harrison and Williams, in their paper referred to above, found a number of sufferers of "resistant urinary incontinence" who refused treatment.
Thus it can be seen that in spite of recent advances in control of incontinence, electrical stimulation of the pudendal nerve, even without surgical procedures, is not accepted in its previously developed form by all sufferers of incontinence.
Turning now to the other aspects of the present invention, the present inventor is unaware of any technique which has been developed for the control of drainage or discharge through a stoma, but does know of the use of electrical treatment of pain.
The electrical treatment of pain is known as transcutaneous electrical nerve stimulation, or "TENS" (sometimes "TNS"). Perhaps the earliest recorded use of TENS was by the Roman physician Scribonius Largus, who used electric ray or torpedo fish for the treatment of headaches. This ancient use of TENS was noted by A. Winter in his paper entitled "The use of electrical stimulation (TNS) in the treatment of multiple sclerosis", which was published in the Journal of Neurosurgical Nursing, Volume 8, December 1976, at pages 125 to 131. TENS has also been described by G. D. Schuster in his paper entitled "The use of TENS for peripheral neurovascular diseases", which appeared in The Journal of Neurological and Orthopaedic Surgery, Volume 1, July 1980, pages 219 to 221. But neither Winter nor Schuster have appreciated that TENS might be of assistance to sufferers of migraine or stress headaches, in the same way as the present invention will be seen to be applicable. Indeed, the brochure which is supplied by Medtronic, Inc. with that company's TENS equipment, refers to the use of TENS in various locations on the body for short-term relief of acute pain, but in its reference (in "appendix C") to control of neuropathic pain in the head, electrodes are placed on the temple and cheek of the patient. There is no suggestion in this brochure that migraine or stress headaches can be controlled by TENS.
Thus, although migraine and stress headaches have been known and experienced for many years (there are references to headaches in the writings of the Babylonian era, and migraine was described in A. D. 81 by a physician, Aretaeus, who practiced in Alexandria), until the present invention was developed there has been no effective control of such headaches. Many techniques have been tried, including acupuncture, the avoidance of certain foods, hypnotherapy and othe psychiatric treatments, but the sufferer usually finds relief, to a degree, in proprietory analgesics, until the headache passes.